Trial document




drksid header

  DRKS00015322

Trial Description

start of 1:1-Block title

Title

Structured outpatient follow-up after stroke

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In Germany, approximately 260,000 people suffer a stroke each year, a figure that will increase over the next few decades due to demographic trends. Stroke is the second most common cause of death worldwide and the third most common cause of obstruction of life years.
With an almost comprehensive range of stroke units and a dense network of rehabilitation clinics, acute care and rehabilitation treatment of stroke in Germany are at a high level. For longer-term assurance of successful treatment, however, there is a lack of structured and quality-assured further care after discharge from acute inpatient or rehabilitation treatment. It has also been shown in several studies that the proportion of patients with risk factors set according to the guidelines after release from acute inpatient treatment is still unsatisfactory.
Structured cross-sector follow-up programs are a potential strategy to tap the full potential of secondary prevention as recommended in current guidelines and to prevent recurrent strokes and other complications. With the help of SANO, the effectiveness of such a follow-up program will be investigated.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The primary question is whether a structured cross-sectoral follow-up program (SNP) can significantly reduce the combined endpoint of recurrent stroke, myocardial infarction or death within one year of stroke compared to standard treatment.
In addition, valid data to guide the setting of risk factors and the rate of hospital admissions and other complications.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

see SANO data sharing plan in the uploaded PDF document

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015322
  •   2018/08/27
  •   [---]*
  •   yes
  •   Approved
  •   2018-131184, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63.0 -  Cerebral infarction due to thrombosis of precerebral arteries
  •   I63.1 -  Cerebral infarction due to embolism of precerebral arteries
  •   I63.2 -  Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries
  •   I63.3 -  Cerebral infarction due to thrombosis of cerebral arteries
  •   I63.4 -  Cerebral infarction due to embolism of cerebral arteries
  •   I63.5 -  Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   At the intervention centers, a cross-sectoral network will be set up before the start of the project, consisting of general practitioners, specialists, sports groups, therapists and other professional groups. After inclusion in the study, a basic examination is carried out. All patients are advised and examined in detail and concrete therapy goals are defined for all individual risk factors. Follow-up examinations take place after 1, 3, 6 and 9 months. Here, the attitude of the risk factors, the medication as well as the medical and auxiliary care of the patients are checked and, if necessary, adjusted. Follow-up visits at 3 and 6 months will be followed by structured screening for possible complications such as depression or cognitive impairment. After 12 months, a detailed final examination is carried out, in which the primary and secondary outcomes are recorded.
  •   Patients in the control group undergo a basic examination after inclusion in the study. Here, the patients are thoroughly examined and receive information about their disease according to the standard of the respective hospital. After 12 months, patients will be invited to a final exam, which will record the primary and secondary outcomes.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Rate of combined outcome in recurrent stroke, myocardial infarction or death within one year of stroke

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Proportion of regulatory risk factors (hypertension, diabetes mellitus, hypercholesterolemia, smoking, diet, physical activity) at one year after stroke
• Therapy adherence regarding antithrombotic medication at one year post stroke
• Rate of hospital admissions within one year of stroke
• Rate of complications (cognitive impairment, depression and anxiety, falls) or their treatment at the time of one year after stroke
• Quality of life at the time of one year after stroke
• Follow-up costs in the first year after stroke

These endpoints are measured using the following tools:
Cognitive limitations MoCA test
Depression / Anxiety PHQ-9 / GAD7
Medication Adherence Medication
Adherence Rating Scale (MARS)
Quality of life EQ-5D-5L
Physical Activity IPAQ / Pedometer
Diet MONICA, nutrition questionnaire

All other secondary endpoints are determined by standardized interviews, examinations or laboratory parameters.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/01/10
  •   2790
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Awareness about the project
No severe disability before index stroke (mRS 0-1)
Insurance in the statutory health insurance
There are at least one of the following risk factors: arterial hypertension, hypercholesterolemia, diabetes mellitus, smoking, atrial fibrillation
written consent to study participation

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Age <18 years
Relevant cognitive impairment, advanced dementia (assessed by the study physician)
mRS after stroke> 3 at the time of screening for the study
Former stroke (ischemic insult or cerebral hemorrhage, former TIAs are not an exclusion cause)
Life expectancy <3 years (due to the time of the screening of known diseases)
Alcohol, medications or drug addiction as assessed by the study doctor
Severe psychiatric illness as assessed by the study physician
Missing family doctor and no willingness to select a family doctor at short notice
No consent of the responsible family doctor to participate in the study
Nursing home or long-term care before the index stroke
Existing legal care of the patient
Inadequate knowledge of German, very severe aphasia
Lack of availability of the clinic for follow-up
No consent to attend the clinic visits after 1, 3, 6 and 9 months
Rare stroke cause for which there are no evidence-based recommendations for secondary prophylaxis (dissection, vasculitis, drug-associated strokes, strokes during pregnancy, etc.)
Participation in drug law (AMG) study
Other reasons according to the study doctor, which can not guarantee the application or implementation of the intervention

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum Ludwigshafen am Rhein
    • Bremserstr. 79
    • 67063  Ludwigshafen am Rhein
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
    • Mr.  Prof. Dr  Peter Uwe  Heuschmann 
    • Josef-Schneider-Str. 2 / Haus D7
    • 97080  Würzburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinikum Ludwigshafen am Rhein
    • Mr.  Prof. Dr.  Armin  Grau 
    • Bremserstr. 79
    • 67063  Ludwigshafen am Rhein
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.